Manufacturers of unapproved prescription products are required to report unexpected, serious adverse events to the Agency per 21 C.F.R. 310.305. Adverse events should be reported on Form FDA 3500A . It is for use by user facilities, distributors, importers, applicants, and manufacturers for mandatory reporting of adverse events and product problems as designated in the applicable statutes and FDA regulations.
Instructions for completing Form FDA 3500A along with questions about mandatory reporting are available. To learn more about submitting reports electronically go to Introduction to FAERS Electronic Submissions.